Events

Notificaciones De Seguridad De Campo acerca de ARCHITECT DHEA-S Reagent Kit

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Abbott GmbH & Co.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-12-14
  • Fecha de publicación del evento
    2018-01-29
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2018/01/29/vazno-obavestenje-o-medicinskom-sredstvu-architect-dhea-s-reagent-kit-imunohemija/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has identified that, when using the architect dhea-s reagent kit, samples from babies up to 60 days of age may have false results. the manufacturer is currently investigating the specific cause of the elevated results. although false elevations have been observed in infants up to 60 days of age, the reference range for children up to 10 years of age given in the test instruction manual should also not be used as the reference ranges are being tested.

Device

ARCHITECT DHEA-S Reagent Kit
  • Modelo / Serial
    (8K27-20) 01316K000; 01217A000; 02217D000; 04117H000;(8K27-25)01216K000; 01117A000; 02217C000; 02317D000; 02417D000; 00517F000; 02817H000
  • Manufacturer
    Abbott GmbH & Co

Manufacturer

Abbott GmbH & Co
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ALIMSA